Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy

Terminated

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT01413945
• Lead Sponsor: Northwell Health

Brief Summary

The aim of the current study is to test the hypothesis that patients with IBS may have a defective ICV pressures and may have small bowel bacterial overgrowth. The goal of the current study is to identify the role and competence of ileocecal valve (ICV) in patients with irritable bowel syndrome.

The primary objective is to measure the pressure of the ileocecal valve in patients with and without irritable bowel syndrome (IBS). The Ileocecal valve reflux pressures during air insufflation of cecum will be used.

Detailed Description

This is an outpatient study. There will be no requirement to stay overnight in the hospital. The research will be conducted in the gastroenterology section of the department of Medicine in North shore university hospital and in North shore long island Jewish medical center. Both these hospitals are tertiary care centers with adequate facilities for the safe and appropriate conduct of this research. Participants must meet all eligibility criteria and sign the consent form before enrolling in the study. This is a cohort study with 2 groups (patients with IBS and participants without IBS). Patients will be enrolled into one of these two categories based on their medical history, signs and symptoms and questionnaire. There are no controlled compounds used in this study. There is no treatment involved in this study. There are 2 study related visits per subject.

Based on questionnaire we plan to recruit 25 participants who meet the criteria of IBS and 25 participants who do not meet the criteria of IBS (Total of 50 participants in the study). Patients with IBS are those who meet the criteria of IBS based on their symptoms and the responses to a validated ROME III - questionnaire. All other participants who do not meet the criteria for IBS are classified as non-IBS participants. All the participants should be having a clinically indicated colonoscopy.

Study Timeline

• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Study Start: 2013-06-21
• Primary Completion: 2015-08-05
• Study Completion: 2017-01-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Patients with a history of small bowel bacterial overgrowth or irritable bowel syndrome and who are undergoing routine colonoscopies or subjects who are undergoing routine colonoscopy and test positive for small bowel bacterial overgrowth will be candidates. If the patient has prior lactulose breath test done for clinical purposes then repeat lactulose breath test will not be required. If no prior lactulose breath test has been performed then it will be done as part of this research study. In addition patients who test negative for SBBO will be candidates for the control population.

Exclusion Criteria

• Medications-Subjects on any medication that could affect the ileocecal valve high-pressure zone will be excluded; this includes use of prokinetic agents, current use of any antibiotics and anticholinergics. Patients will be excluded if the lactulose breath test is done on antibiotics or during the colonoscopy preparation.

GI symptoms, conditions and disorders: In addition exclusion criteria will include a history of ileocecal resection or disease affecting the colon and/or small bowel including crohn's disease, ulcerative colitis or diseases causing diarrhea.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure generated in ICV during Cecal distention	10-15 minutes

Trial Locations

Locations (1)

LIJ Medical Center- NSLIJ Health System; 🇺🇸 New Hyde Park, New York, United States